THE BURDEN of POST-SARS-COV2 VACCINE COMPLICATIONS and NEWLY DIAGNOSED IMMUNEMEDIATED INFLAMMATORY DISEASES

ABSTRACT

Background: Local and systemic reactions have been observed after all vaccines for SARS-CoV-2 but in the majority of cases, symptoms are mild and self-limiting. However, evidence on more severe clinical scenarios, requiring admission to hospital or referral to outpatient clinics after the administration of SARS-CoV-2 vaccines has accrued. This also includes newly diagnosed diseases, such as cardiovascular and immune-mediated infammatory diseases (IMID). Objectives: We aimed at quantifying the burden of post-vaccine hospital admissions/referrals and of newly diagnosed IMID. Methods: Clinical records of patients referred to our Internal Medicine institution (both inpatients and outpatients) between February and June 2021 were retrospectively assessed. Subjects having received one or more doses of any of the EMA-approved SARS-CoV-2 vaccines within the previous 30 days were included. Subjects with a previous diagnosis of IMID were excluded. Results: Our cohort included 99 patients, 45 females and 54 males, with a mean age of 64 years and a median of 3 comorbities (range 0-7). Eighty-eight patients (89%) required admission to the Internal Medicine ward while 11 were referred to the outpatient clinic. 68 (69%) of patients received the vaccine BNT162b2, 16 (16%) the ChAdOx1 nCoV-19, 9 (9%) the mRNA-1273 and 6 (6%) the Ad26. COV2.S. Twenty-seven (27%) subjects developed symptoms after the frst vaccine dose with a mean latency of 2 days (median=0 indicating symptom onset on the day of the vaccine administration). Twenty-four (24%) subjects developed symptoms after the second dose with a mean latency of 4 days (median 1 day). All the other subjects did not develop symptoms within the week after the vaccine and were admitted for reasons apparently unrelated to vaccine administration. The number of presenting complaints ranged between 1 and 4 with 87% of subjects presenting with 1 or two coexisting complaints. Gastrointestinal manifestations were the most frequent being the presenting complaint in 31 (31%) of patients followed by severe fatigue/appetite loss in 19 (19%) of subjects, fever in 18 (18.2%) and neurological manifestation in 16 (16%) of subjects. A temporal and causal association with the SARS-CoV-2 vaccine was identifed since all other known causes for these manifestations were ruled out. No in-hospital deaths were observed and 19 (19%) patients were diagnosed with a new onset IMID (Table 1). The clinical picture of these subjects was not signifcantly different from that of patients without a confrmed IMID and neither were demographic features. No association with the type of vaccine was observed. Conclusion: Our data show that post-vaccine newly diagnosed IMID may represent a challenge in clinical practice and it seems that no demographic or clinical feature is able to predict their onset. A multidisciplinary cooperation and registry data are needed in order to reliably estimate and defne the impact of SARS-CoV-2 vaccinations on new onset IMID.